Quality Assurance Specialist

vor 1 Woche

Frankfurt am Main, Deutschland Lumenis Vollzeit

**About Lumenis**

At Lumenis, our commitment to excellence and innovation is driven by the energy of more than 1,000 professionals worldwide. This allows us to deliver groundbreaking innovations in the ophthalmology and aesthetic fields and to be recognized as the undisputed world leader in energy-based medical devices.

Headquartered in Israel, we are a truly innovative and international organization with a solid global footprint in developed as well as emerging markets, such as the United States, Germany, United Kingdom, China & Hong Kong, Japan, India, Australia, Korea, Singapore, and Taiwan.

**About the role**

The Quality Assurance (QA) Specialist ensures that medical devices meet regulatory and company quality standards through the development, implementation, and maintenance of quality systems. This role supports compliance with applicable regulations (such as FDA 21 CFR Part 820, ISO 13485, and MDR) and is critical in supporting product development, manufacturing and post-market surveillance activities.

**Key Responsibilities**
- Handling Quality aspects: CAPAs, Non-conformance investigations, SCARS, Internal and External audits, etc.
- Updating and writing procedures
- Handling training process
- Managing suppliers’ qualifications and maintaining quality agreements

**Requirements**:

- BSc in Life science/Bio Medical/Electronics/Machine Engineer or other Quality relevant degree
- Experience of at least 5 years in quality positions, preferable from Medical Device/ Pharmaceutical industry
- Familiar with applicable standards and regulations: ISO 13485, EU MDR 2017/745
- Fluent English and German (writing and verbal)
- Strong documentation skills
- Basic computer skills
- Able to manage multiple projects and meet deadlines independently
- Certification as an internal auditor - advantage
- Hybrid work, can work remotely 2-3 days a week
- Must be located at the Frankfurt metropolitan area, up to 2 hours away from our offices

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